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Global Policy Updates

NEWS

Roadmap towards phasing out animal testing for chemical safety assessments

European Commission , 01 Jun 2026

Regions

OECD – New Approach Methodologies (NAMs): OECD activities supporting international harmonisation and regulatory acceptance of NAMs.
OECD Guidance on Grouping of Chemicals and Alternative Approaches: OECD guidance document incorporating alternatives to animal testing in chemical assessment.
ICH M15 Guideline – General Principles for Model-Informed Drug Development: Newly adopted ICH guideline establishing a harmonised framework for model-informed drug development (MIDD), strengthening global regulatory acceptance of computational and mechanistic approaches in pharmaceutical development.
EMA – ICH M15 Scientific Guideline: European Medicines Agency overview of the ICH M15 guideline and its role in integrating modelling and simulation into regulatory decision-making.

FDA Draft Guidance on Alternatives to Animal Testing in Drug Development (2026)
FDA draft guidance supporting the use of NAMs and human-relevant methods in regulatory submissions.
FDA Modernization Act 2.0 Overview Landmark U.S. legislation removing the blanket requirement for animal testing in drug development.

Acceptance of Alternatives to Animal Testing for Quasi-Drugs (2025): Japanese regulatory update on acceptance of alternative methods for regulatory submissions.